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PRODUCTS
(Nucleic Acid Mass Spectrometry)
CE-IVD
BACKGROUND
The incidence rate of lung diseases is increasing year by year, especially the high incidence of pulmonary infectious diseases and lung tumors, which seriously threaten human health and life safety. At present, lung biopsy and lung tissue samples are often performed only by pathological examination. Although pathological examination can identify most of the benign and malignant lesions, it is seldom applied to the diagnosis of infectious diseases. Clinical microbiological examination plays an indispensable role in infectious diseases diagnosis, medication guidance, hospital infection control, antimicrobial management etc. However, this field still faces major problems such as long sample circulation time. For example, in terms of microbial identification, although there are automatic calibrators, which relatively shortens the time, they are mostly based on the principle of microbial biochemical reaction, and still cannot achieve rapid identification. Therefore, clinical microbiology laboratory urgently needs new testing technology to replace the existing technology and achieve new breakthroughs.
DETECTION STRAIN
Strain Name | Abbreviations | Strain Name | Abbreviations | Strain Name | Abbreviations |
Mycobacterium Smegmati | MSM | Mycobacterium Triviale | MTR | Mycobacterium Scrofulaceum | MSC |
Mycobacterium Kansasi | MKA | Mycobacterium Vaccae | MUA | Gastric Mycobacterium | MXE |
Marinum / Mycobacterium Ulcerans | MMA/MUL | Mycobacterium Diernhoferi | MDI | Mycobacterium Phlei | MPH |
Mycobacterium Terrae | MTE | Mycobacterium Neoaurum | MNE | Mycobacterium Tuberculosis | MTB |
Mycobacterium Porcinum | MPO | Mycobacterium Intracellulare | MIN | Mycobacterium Gastri | MGA |
Mycobacterium Avium | MAV | Mycobacterium Chclonae Subsp Chclonae | MCH | Mycobacterium Szulgai | MSZ |
Mycobacterium Chelonei Subsp Abscesses | MAB | Mycobacterium Fortuitum | MFO | Mycobacterium Simiae | MSI |
Mycobacterium Gilvum | MGI | Mycobacterium Nonchromogenicum | MNO | Mycobacterium Aurum | MAU |
Mycobacterium Gordonae | MGO | Mycobacterium Tuberculosis Complex | MTC |
DETECTION METHOD
Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) technology is used to extract nucleic acids from patients' lung tissues. DNA detection technology combined with PCR in vitro amplification and massarray mass spectrometry are used to qualitatively detect the extracted nucleic acids to identify some pathogenic mycobacteria and their subtypes and confirm whether the patient is infected with the microorganism to be tested.
IDENTIFICATION METHOD OF MYCOBACTERIUM SPECIES
Comparison | Sputum Smear Microscopy | Routine Culture + Biochemical Method | Rapid Culture Method | Gene Chip Method | Nucleic Acid Mass Spectrometry |
Sensitivity | Low | High | High | High | High |
Specificity | Low | Low | High | High | High |
Repeatability | Low | Low | Low | High | High |
Clinical significance | Tuberculosis and non tuberculosis cannot be distinguished | A few identifiable strains | Tuberculosis and non tuberculosis can be distinguished, but strains cannot be identified | Mycobacterium tuberculosis complex flora and 22 species can be identified NTM | 25 pathogenic mycobacteria and MTC can be identifiedat one time |
DETECTION SIGNIFICANCE
Accurately identify common clinical MTC and 25 pathogenic mycobacteria, and can distinguish between tuberculosis and non-tuberculous mycobacteria, clarify the etiology, and realize personalized treatment.
Product Name | Detection Method | Pack Size | Instruments Validated | Sample Type |
Human Lung Tissue Mycobacteria Identification Detection Kit | Nucleic acid mass spectrometry | 40 test/kit | MassARRAY®DNA mass spectrometry gene analysis system | Paraffin embedded tissue |
FEATURES & ADVANTAGES
1.Advanced technology: Combined with PCR technology to analyze the nucleic acid molecular level of pulmonary infection bacteria, there is no need for in vitro culture and other processes, reducing manual operation, simple and fast.Only one day for detection results. Large amount of data.
2.Large amount of data: 96 samples can be processed at the same time, and each sample can identify 25 different types or subtypes of pulmonary infectious bacteria at one time.
3.Good specificity: Can tolerate 100 ng wild-type human genomic DNA without non specificity.
4.High sensitivity: Mycobacterial nucleic acid DNA with content as low as 200 copies in 20 ng human genomic DNA can be detected.
DETECTION PROCESS
1.Nucleic Acid Extraction
2.Sample Adding
3.Mass Spectrometry Detection
4.Data Analysis
5.Report